BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222210 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10367
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/28/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS OBSERVED TO BE PEELING AT THE CONTRAST BUTTON. THE UP AND DOWN BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE OK AND CONTRAST BUTTONS RESPONDED PROPERLY. THE KEYPAD WAS REMOVED AND THE UP BUTTON CONTACT WAS OBSERVED TO BE INVERTED AND THE CONTRAST BUTTON CONTACT WAS MISSING. CONTAMINATION WAS OBSERVED UNDER ALL OF THE BUTTON CONTACTS. A CRACK WAS OBSERVED ALONG THE BATTERY COMPARTMENT. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN WAS OBSERVED TO BE DIM WITH A PINK CONTRAST. THE DIM DISPLAY WAS REPLACED WITH A NEW TEST SCREEN AND CONTRAST RETURNED TO NORMAL. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    ANIMAS HAS REQUESTED THE SUBJECT PRODUCTS TO BE RETURNED FOR EVALUATION HOWEVER THE PRODUCTS HAVE NOT YET BEEN RETURNED OR EVALUATED. IF ANIMAS RECEIVES THE PRODUCT ANIMAS WILL INFORM THE FDA OF ANY PRODUCTS THAT FAIL EVALUATION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE UP/DOWN ARROW BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE REPORTER STATED SHE NOTICED THE ALLEGED KEYPAD ISSUE A FEW DAYS AGO. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322620 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR